The Certification Commission forHealthcare Information Technology
Town HallMark Leavitt, MD, PhD
Chair, CCHIT
Karen Bell, MD, MMSDirector, Office of HIT Adoption, ONC
Alisa A. RayExecutive Director, CCHIT
9:45-11:45 AM, Tuesday, Feb 14, 2006HIMSS ’06 Annual Conference
San Diego, CA
Topics
Slide 2
• Introduction• Strategic Role of CCHIT• Scope, Organization, Timeline, Process• Status Report on Phase I:
Ambulatory EHR Certification• Preparation for Phase II:
Inpatient EHR Certification• Opportunities for Participation• Q & A
Introduction
Background
Slide 4
• July 2004: Certification of HIT products a key action in HHS Strategic Framework
• Sept 2004: AHIMA, HIMSS, and the Alliance fund and launch CCHIT
• June 2005: Eight additional organizations add $325k funding support
• July 2005: HHS issues Health IT RFPs• Sept 2005: CCHIT awarded 3 year, $7.5M HHS
contract to develop compliance criteria and inspection process for EHRs and the networks through which they interoperate
Mission of CCHIT
Slide 5
To accelerate the adoptionof robust, interoperable HIT
throughout the US healthcare system,by creating an efficient, credible,
sustainable mechanismfor the certification of HIT products.
Stakeholders and Partners
Slide 6
Private Sector Public Sector
• HHS/ONC• HHS Contractors• Safety Net Providers• Public Health• Federal agencies
• NIST, DoD, VHA,DHS, DoC, NSF,GSA, EPA and others
• Providers• Vendors• Payers/purchasers• Consumers• Quality Improvement• Researchers• Standards Developers
Guiding Principles
Slide 7
• Always protect the privacy of the patient/ consumer’s health information
• Need for decisive private-sector action now• Governance must be credible, objective, and
collaborative• Seek input and deliver compelling value for all
key stakeholders• Inspection process must be objective, fair,
reliable, repeatable• Certification must be efficient, timely, and cost-
effective
Goals of Product Certification
Slide 8
• Accelerate adoption by reducing the risks of investing in HIT
• Facilitate interoperability of HIT products within the emerging national health information network
• Enhance availability of HIT adoption incentives and relief of regulatory barriers
• Ensure that HIT products and networks always protect the privacy of personal health information
Strategic Role of CCHIT
Health IT Deployment Coordination (From AHIC meeting of 1/17/06)
Slide 10
Role of CCHIT within theHHS Health IT Strategy
Slide 11
StandardsHarmonization
ContractorCCHIT:
ComplianceCertificationContractor
Privacy/SecuritySolutionsContractor
Office of the National CoordinatorProject Officers
American Health Information CommunityChaired by HHS Secretary Mike Leavitt
NHINPrototype
Contractors
HarmonizedStandards
NetworkArchitecture
PrivacyPolicies
Governance and Consensus Process EngagingPublic and Private Sector Stakeholders
CertificationCriteria +
InspectionProcess
for EHRsand Networks
Strategic Direction
Accelerated adoption of robust,
interoperable, privacy-enhancing
health IT
Accelerated adoption of robust,
interoperable, privacy-enhancing
health IT
Slide 12
How Product CertificationCan Catalyze HIT Adoption
Payers/Purchasers:
Enhanced quality &efficiency gains from HIT --
unlocking incentives
Providers:Reduced risk,
assured compatibility &financial incentives --accelerating adoption
HIT Vendors:Growing market &
faster sales cycles --lowering costs and
attracting investment
Scope, Organization, Timeline, and Process
CCHIT Scope of Workunder HHS Contract
Slide 14
• Phase I (Oct 05 – Sep 06)• Develop, pilot test, and assess certification of
EHR products for ambulatory care settings• Phase II (Oct 06 – Sep 07)
• Develop, pilot test, and assess certification of EHR products for inpatient care settings
• Phase III (Oct 07 – Sep 08)• Develop, pilot test, and assess certification of
infrastructure or network componentsthrough which EHRs interoperate
Volunteer Organization(Current)
Slide 15
Work Group:Functionality
Work Group:Inter-
operability
Work Group:Security &Reliability
Work Group:Certification
Process
Board ofCommissioners
Work Group:Use Case & Test Plan
Board of Commissioners
Slide 16
• Abha Agrawal, MDDirector, Medical InformaticsKings County Hospital
• Stephen BadgerChief Executive OfficerGWU Medical Faculty Associates
• David W. Bates, MD, MScChief, General MedicineBrigham and Women’s Hospital
• Karen M. Bell, MDDirector, Office of HIT AdoptionONCHIT
• Bruce Nedrow (Ned) Calonge, MDChief Medical OfficerColo. Dept of Public Health & Environment
• Kelly CroninSenior Advisor to the AdministratorCMS
• Suzanne DelbancoExecutive Director The Leapfrog Group
• Jane L. Delgado, PhD, MSPresident and CEONational Alliance for Hispanic Health
• John HummelCorporate CIO & Senior VP of ISSutter Health
• Sam KarpChief Program OfficerCalifornia HealthCare Foundation
• Mark Leavitt, MD, PhDChair, CCHIT
Board of Commissioners(continued)
Slide 17
• Charles Kennedy, MDVP of Clinical InformaticsWellPoint Health Networks Inc.
• Graham O. KingPresident, IT BusinessMcKesson Information Solutions
• Jane B. MetzgerVice President First Consulting Group
• Susan R. Miller, RN, FACMPEAdministratorFamily Practice Assoc. of Lexington, KY
• Susan N. Postal, MBA, RHIAVice President, HIM ServicesHospital Corporation of America
• Wes RishelResearch Director Gartner, Inc.
• John Tooker, MD, MBA, FACPExecutive Vice President / CEOAmerican College of Physicians
• Reed V. Tuckson, MDSenior VP, Consumer HealthUnited Health Group
• Andrew G. Ury, MDChief Executive OfficerPhysician Micro Systems, Inc.
Workgroups
Slide 18
FunctionalityCo-Chair: Sarah T. Corley, MD, Governor, Virginia Chapter, American College of PhysiciansCo-Chair: David Kates, MSEE, MBA , COO, Hx Technologies, IncVincent E. Kerr, MD, President, Care Solutions, UnipriseLynne A. King, RN, BS, MBA, Division Information Officer, Clinical Informatics, University Hospital Health SystemSteven R. Lane, MD, MPH, FAAFP, Clinical Lead, Ambulatory EHR, Sutter Health, Medical Director, HIM, Sutter, Palo Alto Med. Found.Eugenia Marcus, MD, American Academy of PediatricsEric Rose, MD, Product Manager, Physician Micro Systems, Inc.Todd R. Rowland, MD, Director of Medical Informatics, Bloomington Hospital and Healthcare SystemKhiang C. Seow, Director of Software Development - Clinical Enterprise Products and Care Everywhere, Epic Systems CorporationSteven J. Steindel, PhD, Sr Advisor Data Stds Vocab, CDC David L. Winn, MD, CEO, President and Founder, e-MDs Inc.
InteroperabilityCo-Chair: Peter J. DeVault, Director of Enterprise Integration and Interoperability, Epic Systems CorporationCo-Chair: Carol C. Diamond, MD, MPH, Managing Director, Health Program, Markle FoundationRichard Elmore, Vice President, IDX Systems CorporationMary Hall Gregg, PhD, VP Clinical Information Solutions, Quest DiagnosticsPatricia L. Hale, MD, PhD, FACP, CMIO, Glen Falls HospitalDavid C. Kibbe, MD, Director – Center for Health Information Technology, American Academy of Family PhysiciansRonald A. Paulus, MD, MBA, Chief HIT Officer & Special Assistant to the President/CEO, Geisinger Health SystemKent A. Spackman MD, PhD, Professor, Oregon Health & Science University David K. Tao, DSc, IT Architect, Siemens Medical Solutions Health ServicesAlan E. Zuckerman, MD, Primary Care Informatics Program Director, Georgetown University
Workgroups(continued)
Slide 19
Security & ReliabilityCo-Chair: Solomon I. Appavu, Director Systems Planning, John H. Stroger, Jr. Hospital & Cook County Bureau of Health ServicesCo-Chair: John F. Moehrke, BS CS&E, Enterprise Security Architect, GE HealthcareDaniel S. Bormann, BA, MS, Chief Security Officer, Epic Systems CorporationRita K. Bowen, MA, RHIA, CHPS, Chief Privacy Officer/HIM/UR Dir, Erlanger Health SystemEdward J. Coyne, PhD, MA, BS, Security Architect, Veterans Health AdministrationJohn A. Gildersleeve, BA, System Privacy Officer, Geisinger Health SystemJoseph C. Gilfus, BSBA, MBA, Project Manager, Blue Cross Blue Shield of Florida, Inc.Glen F. Marshall, BBA, IT Architect, Siemens Medical SolutionsMarian E. Reed, Corporate Director, Product Security, McKesson Corporation
Certification ProcessCo-Chair: Steve Arnold, MD, MS, CPE, President & CEO, Healthcare Consultants InternationalCo-Chair: Michael L. Kappel, Sr. VP - Government Strategy and Relations, McKesson CorporationBonnie S. Cassidy, MPA, RHIA, FAHIMA, FHIMSS, Independent ConsultantJohn C. Durham, MD, Vice President and Chief Medical Officer, Greenway Medical TechnologiesGerry Hinckley, Partner, Davis Wright Tremaine LLPLinda L. Hogan, PhD, Director, Medical Informatics & Clinical Transformation, Catholic Health EastDan S. Michelson, MBA, Chief Marketing Officer, Allscripts Healthcare SolutionsJoseph H. Schneider, MD, MBA, CMIO, Children's Medical CenterRobert M. Tennant, MA, Senior Policy Advisor, Health Informatics, Medical Group Management Association
Use Case / Test Plan(comprised of members from the other Workgroups)
Co-Chair: Marian E. ReedCo-Chair: Steve Arnold, MD, MS, CPEEdward J. Coyne, PhD, MA, BSPeter J. DeVaultEugenia Marcus, MD
Solomon I. AppavuSteven J. Steindel, PhDRobert M. Tennant, MADavid L. Winn, MDAlan Zuckerman, MD
CCHIT Staff
Slide 20
BoardChairman:
Mark Leavitt
CertificationDevelopment
Director:Lisa Gallagher
Comm.Director:
Sue Reber
Comm.Consultants
ExecutiveDirector:Alisa Ray
Industry Liaisons:Don Mon,Pat Wise,
Amit Trivedi
Business PlanConsultant
WorkgroupCoordinators:Guy Paterson,Kari T Atkins,
Mariann Yeager
ProjectManager:
JoAnn Becker
ExecAdmin Ass’t:Robin Boyd
Comptroller:Merril Prager
Mechanisms to Enhance Openness, Transparency and Credibility
Slide 21
• Commission structure• At least two from provider, payer, and vendor stakeholder groups• At least one from each of seven other stakeholder groups
• Workgroup structure• Two co-chairs from different stakeholder groups• Members represent balance and diversity of stakeholders
• Transparency• Commissioners and WG members disclose potential conflicts of interest• Minutes of all meetings published on CCHIT website• Work products published for Public Comment after each step• All comments reviewed and responses published
• Communication and outreach to stakeholders:• Town Halls – open forum at major conferences• Town Calls – teleconferences with Q & A; open to all• Specific outreach to stakeholder groups• Speaking engagements and press coverage of work
Timeline ofActivities and Deliverables
Slide 22
Q4Develop, publish proposed criteria and test plan
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q320062005 2007 2008
Pilot test and publish report
Final comments, begin certification
Develop, publish proposed criteria
Pilot test and publish report
Develop, publish proposed test plan
Develop, publish proposed criteria
Develop, publish proposed test plan
Phase I:Ambulatory EHR
Phase II: Inpatient EHR
Phase III: Networks
Each Phase includes at least two cycles ofpublic comment during development plus one cycle after pilot test
Final comments, begin certification
Not shown: criteria for each domain are updated annually after initial development Pilot test & publish report
Final comments, begin certification
Development Process
Slide 23
Available Standards
Frameworks
Element X
Step A:Gather Data
ElementDecisionProcess
Criteriafor Mar 2006Requirement X
Roadmap for2007-20082007 2008
Availability in the
marketplace
Priority as seen by
stakeholders
Future X
Do not certify X
Practicality of
certification
Step B:Develop Criteria
Step C: DevelopTest Process
TestScenarios
Step-by-StepTest ScriptsCrosswalk
Step 1Step 2Step 3...
Publish for public comment
Publish for public comment
Development Process
Slide 24
Step D:Pilot Test
Random Selectionof Participants
within eachMarket Segment
Call for Pilot Participation
ConductPilot Tests
Step E:Finalization
Publish for public comment
Refine Test Process and Scripts as Needed
Publish:• Pilot Results• Final Criteria• Final Test Process• Final Test Scripts• Draft Commercial Certification Handbook
• Respond toNew Comments
• Adjust as Needed• Review & Approval
by Commission• Publish Final Version
of all Materials
LaunchCommercial Certification Process
Status Report on Phase I: Ambulatory EHR Certification
• Accomplishments• Current activity: Pilot Test
• Remaining steps
Ambulatory EHR Certification:Accomplishments
Slide 26
• Developed and publishedProposed Final Criteria for 2006
• Developed and publishedRoadmap for 2007 – 2008 Criteria
• Two rounds of Public CommentReceived/responded to >1000 comments
• Developed and publishedTest Process and Test Scripts
Slide 27
Format of the Final Criteria DocumentsExample from Functionality Criteria - “Managing
Allergy and Adverse Reaction List”
Functionality Criteria for 2006:Highlights
Slide 28
• Maintain patient demographic data and identifiers
• Manage problem list• Manage medication list• Manage allergy/adverse
reaction list• Manage patient history
(basic)• Display/print summary
health record• Capture clinical
documents/notes• Capture external
documents• Generate patient-specific
instructions• Create prescriptions• Order diagnostic tests• Manage results (basic)
• Manage consents and authorizations (basic)
• Manage advance directives (basic)
• Care plans (basic)• Drug interaction
checking• Medication and
immunization administration (basic)
• Alerts for disease management, prevention, wellness
• Reminders and notifications
• Task assignment and routing
• Inter-provider communication
• Provider database of access levels
• Scheduling (basic -display from external system)
• Report generation (basic)
• Health record output (basic)
• Encounter management (basic)
• Coding assistance (basic)
• Concurrent access to the record
Interoperability Criteria for 2006:Highlights
Slide 29
• Receive lab results (basic capability in 06; must use defined standard in 07)
• Send electronic prescriptions• This certification requirement becomes effective
Sept 2006• Vendor may comply with ePrescribing standard by
using a partner (i.e. clearinghouse)
• ePrescribing standard must be available in public domain
• Send immunization reports to registryInteroperability continued on next page...
Interoperability Criteria on 2007Roadmap
Slide 30
• Receive lab results using defined standard • Send orders to lab systems• Access to digital images and EKGs• Transmit medication refills• Receive medication fulfillment history• Register documents with network/query network for
documents• Refer or transfer care of patient• Public health reporting• Quality improvement reporting• Practice management interface using defined standard
Note: all are dependent on Standards Harmonization and/orImplementation Guide development
Security/Reliability Criteria for 2006:Highlights
Slide 31
• Control access to system
• Record audit trail of all events
• Require authentication
• Provide encryption for transmission of PHI
• Provide for backup and recovery
• Documented procedures for installation, updating, and protecting from viruses/malware
Inspection ProcessCombines Three Methods
Slide 32
• Self-Attestation• Vendor supplies documentation of the system, signs
attestation as to accuracy
• Jury-observed demonstration• EHR product running at vendor facility, jurors and proctors
observe via simultaneous web conference / audio conference (no travel required)
• Test is 100% guided by published test scripts
• Technical tests• Requires access beyond normal user interface --
administrative access to files, logs, etc. Performed remotely in separate session from demo.
Jury Panels
Slide 33
• For Commercial Certification, panel would be:• Two clinically-experienced jurors (at least one
physician)
• One 1 IT/security juror
• One CCHIT staff member serving as Proctor
• Jurors must sign Conflict of Interest Disclosure as well as Confidentiality Agreement
• Persons with a financial interest in any vendor or product in that market may not serve
Interim Observations fromPilot Test (50% complete)
Slide 34
• General Observations• Virtual web-based testing works well –
no travel costs for vendor or CCHIT
• Validity of Proposed Final Criteria appears high --fewer than 3% of the 300+ criteria need review/rework
• Concerns being addressed:• Test duration running 5 – 9 hrs. Plan to reduce to 4
hours by eliminating duplication in scenarios and emphasizing importance of vendor preparation
Interim Observations fromPilot Test (50% complete)
Slide 35
• Jury Process• Including a practicing clinician is essential
• Juror training/orientation is essential – must judge system against CCHIT criteria and not personal expectations
• Concerns being addressed:• Jury “deliberation until consensus reached” model does
not appear optimal. Working on alternative voting/resolution models.
Interim Observations fromPilot Test (50% complete)
Slide 36
• Test Scripts• Use of clinically relevant scenarios is proving to
be appropriate
• Concerns being addressed:• Second and third scenarios cover some criteria already
tested. Simplify scripts to reduce duplication.
• Security testing to be removed from scenario portion and made part of technical test.
Interim Observations fromPilot Test (50% complete)
Slide 37
• Documentation / self-attestation portion• Vendors need clearer guidance of what is required – CCHIT
needs to provide examples.
• Usability• Jurors need clear guidance that “usability” (speed,
efficiency of workflow) is not being tested in 2006
• Other• Vendors should use production configuration, not ‘demo
version’ with capabilities omitted
• Policy regarding technical aberrations during observed demo
Key Activities and Datesto Complete Phase I
Slide 38
• Complete the Pilot Test – Feb 28• Publish results – March 3• Prepare and publish draft of
Commercial Certification Handbook – March 3• Public Comment period on all of above –
March 3 – March 31• Workgroups make final adjustments to Criteria and Test
Scripts based on Pilot Test results and Public Comments• Review and Approval of final package by Commission --
April 24• Begin accepting applications late April 2006• First round of certification results June 2006
Commercial CertificationHandbook – Topics to Address
Slide 39
• Pricing of Certification
• Duration of certification (3 years)
• Software versions and updates (self-attestation for updates, but need clear definition)
• Application process and test scheduling
• Preparation and education resources for vendors
• Pre-test “desktop review” of applications
• Retest and appeal process
Commercial CertificationHandbook – Topics to Address
Slide 40
• Validation of operational use at ‘live site’
• Options for pre-market conditional certification
• Questions regarding certifying self-developed, non-marketed EHRs
• Certification announcement batching and scheduling
• Communication guidelines for vendors
• Process for handling end-user complaints
Preparation for Phase II: Inpatient EHR Certification
Ambulatory vs Inpatient EHRs:Contrasting the Environments
Slide 42
Ambulatory Inpatient
Organization size Most < 10 people Many > 1000 people
Purchase price $10k - 500k $1M - $50M
Total market ~$2B ~$20B
Installation time 2 – 6 months 1 – 5 years
1 (“single vendor”strategy)
2-5 (“best of suite”strategy)
>5 (“best of breed”strategy)
Number of vendors supplying EHR
components at a single site
1 or 2
Initial Thoughts on Inpatient EHR Certification – Discussion Invited
Slide 43
• Functionality• Impractical to cover the broad spectrum of all inpatient
workflows with any reasonable set of criteria• CCHIT should focus on functional areas of high potential benefit
and low current penetration. Candidate: Quality and Safety Systems (e.g., CPOE - CDSS – Pharmacy - Med Admin loop)
• Interoperability• Others are addressing intra-enterprise data exchange standards• CCHIT should focus on external portability of the record:
hospital-to-hospital, hospital-to-physician, hospital-to-patient• Security
• Important area for potential CCHIT contribution
CCHIT Organization(Proposed Phase II Structure)
Slide 44
Board of Commissioners
Operations OversightCommittee
Business AdvisoryCommittee
Coordinator:Ambulatory Functionality
(Comprehensive EHR)
CertificationDevelopment
Director
AmbulatoryFunctionality
CriteriaWorkgroup
AmbulatoryFunctionality
TestingWorkgroup
Coordinator:Inpatient Functionality
(Quality & Safety Focus)Inpatient
FunctionalityCriteria
Workgroup
InpatientFunctionality
TestingWorkgroup
Coordinator:Interoperability
(Ambulatory & Inpatient)
Interop.Criteria
Workgroup
Interop.Testing
Workgroup
Coordinator:Security
(Ambulatory & Inpatient)
SecurityCriteria
Workgroup
SecurityTesting
Workgroup
Chair
ExecutiveDirector Commercial Certification Process
Advisory Workgroup
Opportunities for Participation
Opportunities for Participation
Slide 46
• Today – EHR Vendor Orientations• 12:30 – 1:30pm, repeated 1:30 – 2:30 pm • Mezzanine room 13
• Provide your input• Online public comments - posting March 3, deadline March 31• Participate in Town Calls and other outreach events
• Volunteer as Workgroup Co-Chair or Member• Applications open Feb 17, deadline March 3
• Nominate a Juror, or Volunteer as a Juror• Applications open soon
• Serve on the Commission• Nominations open this summer
Top Related